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Moving Diagnostics to the Forefront of Precision Medicine


Diagnostics tests are critical for properly applying precision medicine in cancer care, yet they are still undervalued by payers. In this episode, we had the privilege of speaking with Hannah Mamuszka, founder of Alva10, a company aimed at breaking the cycle of commoditization in diagnostics and bringing radically new tests to bear on value-based healthcare.

Our conversation centered around the hurdles diagnostic companies face getting technology accepted and used for patients within our health care system—one of the biggest hurdles being reimbursement.

Hannah Mamuszka headshot current 1_edite
Moving Diagnostics to the Forefront of Precision Medicine - Hannah Mamuszka
Listen to the full episode above to learn more and download the transcript here.

Hannah is trained as a molecular biologist and worked for several pharmaceutical companies before founding Alva10.


Today, her vision is to broker better relationships between health insurance companies and diagnostic developers who have the technology that can really impact health care.


During our discussion, she talked about diagnostics as a downward cycle of low value leading to poor precision medicine. For instance, she says, many of the diagnostic tests that are valued at between $100 and $200 are guarding access to drugs that cost between $150,000 to $250,000, which is an enormous disparity in value when the access to the drug is completely predicated on that diagnostic test.


I asked her to explain some of the forces driving this discrepancy, and she pointed out that both diagnostic companies and payers share some of the blame. On the one hand, diagnostic companies rush tests to market without first validating them, because of inadequate funding and because in order to apply for a CPT code through the AMA, a test first has to be used by "many labs." On the other hand, payers are inundated with requests for reimbursement for tests that aren’t validated, which has translated into poor coverage, low value, and a fee-for-service reimbursement system that doesn't allow for innovation.


Hannah says it is in the interest of the patients, payers and the diagnostic companies to have the most robust diagnostic tests. It allows the diagnostic labs to make an argument for value, allows the payers to not pay for therapies that are ineffective, and adverse events that are unnecessary, and it allows the patient to have a better shot of going on a therapy that they're going to benefit from. However, she points out, that may not all be in the interest of pharmaceutical companies if it will shrink their market.


Some people have suggested that Pharma companies should have control of developing diagnostics, but Hannah argues that in order for there to be a robust diagnostic market, it has to be able to stand on its own feet, develop its own tools, and establish itself in a way that increases the perceived value of diagnostics.


At Trapelo™, we work towards creating greater access and scale of precision medicine by eliminating financial and administrative burdens like prior authorization, so I was curious what concerns around paying for genomic tests Hannah has heard in her conversations with insurance companies and if they see a future where diagnostic companies are reimbursed consistently at profitable rates to encourage innovation.

To hear her response, listen to the full podcast above or download the full PDF transcript here.


Hannah’s insights are invaluable at this stage in the evolution of precision medicine, and we are grateful we had the opportunity to hear her thoughts.


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About Our Guest

Hannah Mamuszka, Founder and CEO of Alva10


Ms. Mamuszka is a senior executive in the Cambridge, MA biotech community, with extensive experience in both drug and diagnostic development, validation, and commercialization. With more than 20 years of experience in healthcare from the bench to the business side, she believes that diagnostics are the key to Precision Medicine. Her thorough command of cutting-edge science compliments her business acumen when evaluating the complex diagnostics deals that shape this industry. She is a well-respected voice for diagnostics in the industry, and a natural choice to bring change to this field.


Twitter: @Hannah_Mamuszka



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